PACIFIC-5: Phase III study of durvalumab after either concurrent or sequential chemoradiotherapy (CRT) in patients with stage III NSCLC

Abstract Background Non-small-cell lung cancer (NSCLC) represents >80% of lung cancer cases worldwide and 30% of patients (pts) present with Stage III disease. Historically, platinum-based CRT has been the standard of care (SoC) for such pts, yet outcomes are poor. Durvalumab (durva) is a selective, high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. Results from the PACIFIC trial of durva in pts with locally advanced, unresectable, Stage III NSCLC, who did not progress on concurrent CRT (cCRT), showed significant improvements in progression-free survival (PFS) and overall survival (OS) with durva vs placebo (PFS: HR 0.52; 95% CI 0.42–0.65; P  Trial design PACIFIC-5 is a phase 3, randomized, double-blind, placebo-controlled, multicenter study. Approximately 360 pts with histologically or cytologically confirmed Stage III, locally advanced, unresectable NSCLC will be enrolled from China and the rest of the world. Eligible pts have not progressed following definitive, platinum-based cCRT or sCRT, and are in complete response, partial response or have stable disease. Pts are being randomized 2:1 to receive either durva (1500 mg i.v.) every 4 weeks, or placebo, until disease progression, toxicity or withdrawal of consent. The primary endpoint is PFS per blinded independent central review; OS is the key secondary endpoint. Other secondary endpoints include OS24, overall response rate, duration of response, PFS2, PFS12, PFS18, time to distant metastases, pt-reported outcomes, durva pharmacokinetics and immunogenicity, and safety assessments. Recruitment is ongoing. Clinical trial identification NCT03706690. Legal entity responsible for the study AstraZeneca. Funding AstraZeneca. Disclosure Y-L. Wu: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self): Pierre Fabre; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Advisory / Consultancy: Merck; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim. Y-C. Kim: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Boehringer Ingelheim. P. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. Y. Qin: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. E. Macpherson: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P.A. Dennis: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.